CompletedPhase 1

Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers

CanadaStarted 2003-05

Plain-language summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia. PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.

Who can participate

Age range

40 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37 * Current or former smokers who have smoked at least 30 pack years * Sputum cells showing AIC atypia by computer-assisted image analysis * At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia * At least 1 site confirmed by bronchial biopsy * Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm * No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer PATIENT CHARACTERISTICS: Age * 40 to 74 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Hematologic function normal * No bleeding disorder Hepatic * Liver function normal * Liver enzymes no greater than upper limit of normal Renal * Renal function normal Cardiovascular * No unstable angina * No congestive heart failure Pulmonary * No acute or chronic respiratory failure * No acute bronchitis or pneumonia within the past month Other * Fasting glucose less than 144 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to have a bronchoscopy * No schizophrenia * No bipolar disorder * No diabetes * No known reaction to topical xylocaine * No other medical condition that would jeopardize patient safety du…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00061997

SponsorBritish Columbia Cancer Agency

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Lung Cancer trials